Manufacturer

Huvitz

South KoreaLegal entities : Huvitz Co., Ltd.

Markets : France · Germany · Italy · United States

Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 6 · class I, II · latest in 2023 · see on the FDA website

EU representative : MDSS GmbH (Germany)

Website

14 categories, 15 models including 15 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Ophthalmometers	Z12120113	HRK-9000A, HRK-8100A, HRK-8000A, HRK-7000A, HRK-1, HRK-7000, ERK-91003 refs HVS-1	I MDR	EUDAMED record Report an error
Computerised corneal topographs	Z12120123	HUVITZ HTG-1, HRKT-1	IIa MDR	EUDAMED record Report an error
Computerised optical biometers	Z12120102	HUVITZ HBM-1	IIa MDR	EUDAMED record Report an error
Medical support equipment - other	V0899	CIT-4100, CIT-42002 refs	I MDR	EUDAMED record Report an error
Ophthalmological instrument stands	Z12129001	HRT-7000, CIT-40002 refs	I MDR	EUDAMED record Report an error
Ophthalmoscopes	Z12120114	HUVITZ HFC-1	IIa MDR	EUDAMED record Report an error
Optical consistency tomographs	Z12120121	OCTavius HOCT-1F, HOCT-1	IIa MDR	EUDAMED record Report an error
Optometers	Z12120115	HUVITZ HDR-7100P, HDR-7000P, HDR-9000, HDR-70003 refs	I MDR	EUDAMED record Report an error
Peripheral vision analysers	Z1212012003	HUVITZ HVF-100	I MDR	EUDAMED record Report an error
Slit lamps	Z12120108	HS-5000, HS-5000(X2), HS-5000(X3), HS-5500, HS-7000, HS-7500 and HIS-5000U2 refs	I MDR	EUDAMED record Report an error
Tonometers	Z12120122	HUVITZ HTR-1A, HNT-1P, HNT-1, HT-50002 refs	IIa MDR	EUDAMED record Report an error
Various ophtalmology instruments - medical device software	Z12129092	HUVITZ HIIS-1	IIa MDR	EUDAMED record Report an error
Various ophtalmology instruments - other	Z12129099	HLM-1, HLM-7000P, HLM-90003 refs	I MDR	EUDAMED record Report an error
Visual functional assessment equipment	Z1212012001	HUVITZ HDC-9100 N, HDC-9100 PF, HCP-7000, HDC-100, HDC-9000 N, HDC-9000 PF3 refs	I MDR	EUDAMED record Report an error

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